Validations Scientist I

at Fresenius Kabi USA, LLC in Melrose Park, Illinois, United States

Job Description

Job Summary

The Scientist I (Validations) will be responsible for intermediate validation tests within the validation, implementation, and periodic review of Quality Control's laboratory instruments and critical equipment, to meet established and expected quality, regulatory and customer requirements.

Responsibilities

Perform periodic reviews for analytical instrumentation, computerized systems, environmental chambers for the Quality Control Laboratories.
Generate instrument qualification protocol documents; schedule and execute equipment qualification per standard operation procedures (SOPs).
Schedule and execute equipment re-qualification per standard operation procedures (SOPs).
Change controls for validation-related protocols and instrument changes /upgrades.
Coordinate validation testing. Assemble final reports and circulate for approval.
Interact with regulatory agencies, as required, for validation-related activities.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

JOB REQUIREMENTS
Bachelor's degree in science or engineering
Minimum of one year validation experience preferably in a pharmaceutical or other similarly regulated industry
Working knowledge of cGMP regulations.
Strong project management skills.
Strong oral and written communication skills.
Ability to troubleshoot and proven problem solving skills

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.